NEW PRODUCT INTRODUCTION (NPI) MANAGER

Marmon Holdings, Inc.; Angola (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

Precision Edge Surgical Products Company LLC is seeking a Manager of New Product Introductions (NPI) to lead the engineering team in transferring new medical device products from development into commercial manufacturing. You will liaison across functions to ensure on-time launches within budget and regulatory compliance.

The ideal candidate has extensive medical device product development and manufacturing operations experience, strong project management skills, and proven leadership in a

Qualifications

• Bachelor’s degree in engineering and 10–15 years in medical device manufacturing.
• Experience with ISO 13485 and 21 CFR 820.
• Proven supervisory experience leading cross-functional teams.
• Ability to use SolidWorks and ERP/workflow tools.

Responsibilities

• Lead engineering team through transfer of new products to manufacturing.
• Coordinate with Business Development, Quality, Procurement and Supply Chain.
• Manage NPI process from customer request to launch.
• Ensure regulatory compliance and budget adherence.
• Develop prototype processes and training.

Skills

NPI management

Cross-functional leadership

Project management

Quality systems

Leadership

Education

Bachelor’s degree in engineering

Tools

SolidWorks

ERP software

Smartsheet

SharePoint

Job description

Precision Edge Surgical Products Company LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Position Summary
The Manager of New Product Introductions (NPI) is responsible for leading the engineering team in the successful transfer of new medical device products from development into commercial manufacturing. This role serves as a key liaison between Business Development, Quality, Procurement, Supply Chain, Manufacturing, Accounting, and external suppliers to ensure products are launched on time, within budget, and in compliance with applicable regulatory requirements.
The ideal candidate will have strong experience in medical device product development, manufacturing operations, project management, and cross-functional leadership within a regulated environment.

Key Responsibilities

• Manages the quoting process across the Marmon Medical Manufacturing (MMM) Platform
• Manages customer expectations with new products including, up front design work, medical device performance, Design for Manufacturability (DFM).
• Coordinates and manages the NPI process from customer request to product launch or launch handoff to onsite engineering teams.
• Understands manufacturing processes and process capabilities across all MMM manufacturing sites.
• Works closely with Business Development, Engineering, Quality, Supply Chain, Operations, Accounting, and Procurement to meet company goals,
• Develops and maintains a formal prototype process utilizing nonproduction equipment
• Create a team-based environment with a positive atmosphere
• Ensure that personnel are trained for their job positions and have relevant goals established that align with company goals
• Assists annually with the budget setting process and strategic planning
• Supports Monthly Management Report (MMR) analysis and generation
• Champion for Health, Safety and Environment standards

Key Competencies

• Strong background in CNC and automated manufacturing processes
• New product release (NPR)
• Estimating
• Collaboration
• Customer Focus
• Technical support
• Resource Management
• Change Management
• Project Management
• Effective leadership
• Coaching and Employee Development
• Strategic Planning
• Problem Solving Skills

Qualifications

Required

• Bachelor’s degree in engineering
• 10-15 years’ experience in medical device contract manufacturing, product development and production launch
• Knowledge of ISO 13485 and 21 CFR 820
• Supervisory experience leading teams
• Ability to use SolidWorks, navigate ERP software, utilize workflows such as Smartsheet and SharePoint

Preferred

• Advanced Degree in Engineering
• Experience in cost estimating and prototype processes

Reports To

• Director of Engineering and Quality

FLSA Status

• Salary Exempt

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [e-mail], and please be sure to include the title and the location of the position for which you are applying.